This course has been updated to include the new revised EU GMP Annex 11, and an update on 21 CFR Part 11.

This three-day fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements.

The course does not aim to cover detailed and highly technical aspects of software and hardware engineering, but rather gives the principles and an overview of the overall computer systems compliance process, including a scaleable and efficient system lifecycle, Quality Risk Management , updated GAMP categories, the role of the supplier, and the selection of appropriate specification and verification activities.

Course Topics Include:

What are the FDA and EU regulatory requirements for GxP computerized systems?

A Risk-based approach to Electronic Records and Signatures to meet both FDA and EU Expectations

Attendance Suggested for:

Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, MIS professionals and all levels of management who need a fundamental understanding of computerized system compliance and regulations

Computer system vendors or consultants, engineering contractors, and validation service companies

Group Discounts

3 - 5 participants - Save 10%

6 - 10 participants - Save 15%

11 or more participants - Save 20%

To qualify, all registrant information must be submitted at the same time. Only ONE payment to cover all registrations will be accepted. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105.

Group Discounts

3 - 5 participants - Save 10%

6 - 10 participants - Save 15%

11 or more participants - Save 20%

To qualify, all registrant information must be submitted at the same time. Only ONE payment to cover all registrations will be accepted. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105.

Group Discounts

3 - 5 participants - Save 10%

6 - 10 participants - Save 15%

11 or more participants - Save 20%

To qualify, all registrant information must be submitted at the same time. Only ONE payment to cover all registrations will be accepted. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105.

Group Discounts

3 - 5 participants - Save 10%

6 - 10 participants - Save 15%

11 or more participants - Save 20%

To qualify, all registrant information must be submitted at the same time. Only ONE payment to cover all registrations will be accepted. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105.

Group Discounts

3 - 5 participants - Save 10%

6 - 10 participants - Save 15%

11 or more participants - Save 20%

To qualify, all registrant information must be submitted at the same time. Only ONE payment to cover all registrations will be accepted. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105.

Group Discounts

3 - 5 participants - Save 10%

6 - 10 participants - Save 15%

11 or more participants - Save 20%

To qualify, all registrant information must be submitted at the same time. Only ONE payment to cover all registrations will be accepted. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105.